On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule
The COVID-19 Pandemic wreaked havoc on many businesses. For others, though, it created new opportunities to sell to the federal government, including an unprecedented demand for personal protective equipment (“PPE”), COVID tests, and vaccines. Perhaps your company found itself as a first-time government contractor, or you started selling products to the government that you had never sold before. If your government contract went smoothly, congratulations! If not, you may be left wondering who will pay for unexpected increased costs of performance, or how you can defend against the government’s claims to recoup overpayments or liquidated damages. Continue Reading Don’t Leave Money on the Table from Your Pandemic-Era Healthcare Procurement Contract
The government buys billions of dollars in healthcare-related goods and services every year, and no government procurement is perfect. In a business where every contract award matters, healthcare contractors should be aware that they may have a second chance at winning a contract if the government agency made a material error in its procurement process. The question disappointed healthcare contractors should ask is whether the agency acted unreasonably in its evaluation and selection of the awardee. If the answer is “yes”—or even “maybe”—healthcare companies may file a bid protest at the Government Accountability Office (“GAO”) or the U.S. Court of Federal Claims (“COFC”) challenging the award. If successful, the agency will often need to reevaluate proposals and make a new award, giving protestors another opportunity to be selected.Continue Reading A Second Chance to Win Your Government Healthcare Contract
Companies regularly are required to interpret ambiguous and vague regulatory provisions. Today, the United States Supreme Court heard oral arguments in a pair of consolidated cases to determine whether a defendant’s subjective interpretation of an ambiguous regulation is relevant to determining the knowledge (or scienter) element of the False Claims Act or, as the Seventh Circuit held in the case below, that once a defendant can articulate an objectively reasonable interpretation its contemporaneously held subjective belief is irrelevant to the knowledge inquiry. The issue is a significant one for both the government and relators on one side, and potential defendants on the other, as False Claims Act (FCA) liability imposes treble damages and penalties exceeding $20,000 per claim as well as relators’ attorneys’ fees and costs.Continue Reading Supreme Court Hears Arguments on False Claims Act Scienter Standard
On January 30, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the long-delayed final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”). CMS promotes the Final Rule as improving program integrity and payment accuracy as well as transparency and certainty. One thing that is certain, CMS can expect further challenges to its RADV audit methodology.Continue Reading CMS Issues Long-Awaiting Medicare Advantage RADV Final Rule
Just in time for the holidays, the Centers for Medicare and Medicaid Services (“CMS”) issued the Contract Year 2024 Proposed Rule for Medicare Advantage organizations (“MAOs”) and Part D sponsors (the “Proposed Rule”). The Proposed Rule includes changes on an array of topics including: Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, behavioral health services, identification of overpayments, requirements for valid contract applications, and formulary changes. Continue Reading CMS Issues CY2024 Proposed Rule for Medicare Advantage Organizations and Part D Sponsors
Last month, the U.S. Department of Health and Human Services Office of Inspector (“OIG”) released a report that studied prior authorization denials and payment denials by Medicare Advantage Organizations (“MAOs”)…Continue Reading HHS OIG Report On Prior Authorizations Under Medicare Advantage
It’s official: the Department of Veterans Affairs (“VA”) Medical Surgical Prime Vendor (“MSPV”) 2.0 Program is no more. The VA has announced that it will not revive MSPV 2.0 following several unusually painful protests at the U.S. Court of Federal Claims (see our prior blogs here and here). Instead the VA will move on to MSPV-“Z”. Generally speaking, there seems to be little difference between “2.0” and “Z,” except that some division of geographies may change. But importantly, the VA plans to make clear in the MSPV-Z solicitation—which currently is in the works—whether and when it will transfer the contracts’ requirements to the Defense Logistics Agency (“DLA”), an issue that has drawn significant criticism to date. The VA says it is developing the business case for the transfer, and the business case analysis will determine both whether it will happen at all, and how the VA will execute the transfer. In the meantime, the VA will extend the current bridge contracts under MSPV-Next Generation (“MSPV-NG”) for a full year, running December 2021 to December 2022, while the VA (and likely the DLA) get their ducks in a row.
Continue Reading MSPV 2.0 Is Dead – Long Live MSPV
Ignore our prior prediction—the U.S. Court of Federal Claims definitely is NOT remanding the protest by Medline Industries, Inc. (“Medline Protest’) to the agencies for corrective action. In a surprisingly scathing opinion issued June 22, 2021 by Judge David A. Tapp, the court made one thing very clear—the Department of Veterans Affairs’ (“VA”) transfer of its Medical Surgical Prime Vendor (“MSPV 2.0”) requirements to the Defense Logistics Agency (“DLA”) is dead on arrival. After issuing a brief order on June 17 denying remand to the agencies for corrective action, the court detailed its reasoning in an opinion issued in a parallel protest filed by Owens & Minor Distribution, Inc. challenging (slightly) different aspects of the shifting MSPV 2.0 procurement (“O&M Protest”). The government had moved for remand in both protests, and because the Medline Protest and O&M Protest involved the same parties and many common operative facts, the court issued a single opinion denying remand in both—and telegraphing that the outlook for the government in both cases is grim. Piling on, the court took a few shots at the government for its litigation conduct and (more generally) its lack of acquisition planning.
Continue Reading Duck Hunt – The VA Cannot Escape The Medline Protest, And Takes A Few Shots In The Process
The U.S. Department of Veterans Affairs (“VA”) Medical Surgical Prime Vendor (“MSPV”) 2.0 Program (discussed previously here and here) has yet to make it off the ground, but in March 2021 the VA announced plans to eliminate the program by September 2023 and instead purchase from the Defense Logistics Agency’s (“DLA”) separate MSPV catalog. The VA and DLA MSPV programs are how the VA and DLA (separately) purchase most of their medical, surgical, and laboratory equipment for care centers across the country (and abroad, in the case of DLA). The VA and DLA have been exploring the possibility of consolidation since at least January 2019, but many vendors relied on the VA’s representations that it would not make any decisions on potential consolidation until at least 2025. So when the VA informed stakeholders of its new September 2023 target, Medline Industries, Inc. (“Medline”), one of the prime vendor awardees under the VA’s MSPV 2.0 Program, responded by filing a bid protest at the U.S. Court of Federal Claims. On May 28, 2021, the VA and DLA decided to take corrective action, asking the Court for six months to re-evaluate the issues raised by the protest. It seems that the government did not have all of its ducks in a row prior to announcing the targeted transition.
Continue Reading Ducks (Not) in a Row – VA Agrees to Take Corrective Action in Transitioning MSPV 2.0 Requirements to DLA